Status:
ACTIVE_NOT_RECRUITING
Oscillating Positive Expiratory Pressure Therapy for Patients With Thoracic Neoplasms Undergoing Chest Surgery
Lead Sponsor:
Instituto Nacional de Cancerologia de Mexico
Conditions:
Lung Cancer
Mediastinal Tumor
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This randomized clinical study aims to assess the use of an oscillating positive expiratory pressure device (AEROBIKA) in patients with thoracic neoplasms who undergo chest surgery. The main question...
Detailed Description
Clinical evaluation 1. At patients´ first visit, demographic, clinical, and imaging variables will be obtained from INCan medical history and electronic record. 2. The patient will be called one week...
Eligibility Criteria
Inclusion
- Patients with a confirmed diagnosis of lung cancer, mediastinal tumors or mesothelioma who are candidates for surgical resection through thoracotomy or sternotomy.
- Measurable disease
- Age from 18 to 75 years
- Peak Expiratory flow of 10 liters/min
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Karnofsky score 70-100
- Patients willing and able to comply with all study procedures and follow-up visits.
- Patients who agree to participate and sign an informed consent form
Exclusion
- Unstable systemic disease, including active infection, cardiac or hemodynamic diseases or neurological diseases.
- Patients with cognitive impairment who are not able to perform the pulmonary rehabilitation exercises.
- Oral cavity or facial trauma.
- Esophagus surgery
- Active hemoptysis
- Tympanic rupture or middle ear pathology.
Key Trial Info
Start Date :
August 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05267496
Start Date
August 13 2019
End Date
December 31 2025
Last Update
May 1 2025
Active Locations (1)
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1
Instituto Nacional de Cancerologia
Mexico City, Mexico, 14080